U.S. patent application number 15/061990 was filed with the patent office on 2016-07-28 for illuminated suction apparatus.
The applicant listed for this patent is Invuity, Inc.. Invention is credited to Fernando Erismann, Douglas Rimer, Alex Vayser, Vladimir Zagatsky.
Application Number | 20160213233 15/061990 |
Document ID | / |
Family ID | 50339517 |
Filed Date | 2016-07-28 |
United States Patent
Application |
20160213233 |
Kind Code |
A1 |
Vayser; Alex ; et
al. |
July 28, 2016 |
ILLUMINATED SUCTION APPARATUS
Abstract
An illuminated suction apparatus including a hand-held surgical
device combining a high-performance non-fiber optic optical
waveguide with suction. This device is useful in a wide array of
surgical procedures including open and minimally invasive
orthopedics.
Inventors: |
Vayser; Alex; (Mission
Viejo, CA) ; Erismann; Fernando; (New York, NY)
; Rimer; Douglas; (Los Altos Hills, CA) ;
Zagatsky; Vladimir; (San Francisco, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Invuity, Inc. |
San Francisco |
CA |
US |
|
|
Family ID: |
50339517 |
Appl. No.: |
15/061990 |
Filed: |
March 4, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14732617 |
Jun 5, 2015 |
9308054 |
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15061990 |
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14057947 |
Oct 18, 2013 |
9072452 |
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14732617 |
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13712029 |
Dec 12, 2012 |
8795162 |
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14057947 |
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13328773 |
Dec 16, 2011 |
8568304 |
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13712029 |
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13619574 |
Sep 14, 2012 |
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13712029 |
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12616095 |
Nov 10, 2009 |
8292805 |
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13619574 |
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61423813 |
Dec 16, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 1/008 20130101;
A61B 1/06 20130101; A61B 2090/306 20160201; A61B 1/015 20130101;
A61M 1/0031 20130101; A61B 1/07 20130101; A61M 1/0025 20140204;
A61M 1/0039 20130101; A61M 2205/587 20130101; A61B 90/30 20160201;
A61N 1/04 20130101; A61B 1/0017 20130101; A61B 1/00135 20130101;
A61B 1/0607 20130101 |
International
Class: |
A61B 1/015 20060101
A61B001/015; A61B 1/07 20060101 A61B001/07; A61M 1/00 20060101
A61M001/00; A61B 1/06 20060101 A61B001/06 |
Claims
1. A hand-held illuminated suction device comprising: a suction
tube having a proximal portion and a distal portion; an optical
waveguide having a proximal region and a distal region, wherein
light is transmitted from the proximal region toward the distal
region thereof by total internal reflection; a first handle coupled
to the proximal portion of the suction tube and also coupled to the
proximal region of the optical waveguide, wherein the first handle
is disposed around the proximal region of the optical waveguide;
and at least one total internal reflection (TIR) preserving element
coupled to the optical waveguide, wherein the at least one TIR
preserving element is configured to promote total internal
reflection of the light passing through the optical waveguide.
2. The device of claim 1, wherein the first handle is disposed
around the proximal region of the optical waveguide, and wherein
the at least one TIR preserving element comprises an air gap
disposed between the first handle and the proximal region of the
optical waveguide.
3. The device of claim 2, wherein the at least one TIR preserving
element further comprises one or more standoffs disposed between
the proximal region of the optical waveguide and an interior wall
of the first handle, the one or more standoffs maintaining the air
gap disposed between the first handle and the proximal region of
the optical waveguide.
4. The device of claim 1, wherein the first handle is ergonomically
configured to fit in an operator's hand.
5. The device of claim 1, further comprising a pistol grip handle
coupled to the first handle.
6. The device of claim 1, wherein the proximal portion of the
suction tube is configured to be fluidly coupled to a vacuum
source, and wherein the distal portion is configured to remove
fluid or debris from a surgical field.
7. The device of claim 1, wherein the suction tube comprises an
outer surface and the optical waveguide is disposed over the outer
surface of the suction tube.
8. The device of claim 1, wherein the distal region of the optical
waveguide comprises a plurality of light extraction features
configured to direct the light distally to illuminate a surgical
field.
9. The device of claim 1, wherein the at least one TIR preserving
element comprises an optical cladding disposed over an outer
surface of the optical wave guide.
10. The device of claim 9, wherein the optical cladding is further
configured to prevent or minimize contact between the optical
waveguide and fluid, debris, or tissue in a surgical field.
11. The device of claim 9, wherein the first handle is disposed
over at least a portion of the optical cladding.
12. The device of claim 9, wherein the optical cladding comprises a
TIR promoting coating.
13. The device of claim 9, wherein the at least one TIR preserving
element comprises an air gap between the optical cladding and the
optical waveguide, and wherein the optical cladding is configured
to maintain the air gap.
14. The device of claim 1, wherein the at least one TIR preserving
element comprises an air gap between a portion of the suction tube
and a portion of the optical waveguide, wherein the at least one
TIR preserving element further comprises one or more standoffs
disposed between the optical waveguide and the suction tube, and
wherein the one or more standoffs prevent engagement between the
portion of the suction tube with the portion of the optical
waveguide thereby maintaining the air gap.
15. A method of illuminating tissue in a surgical field of a
subject, said method comprising: providing an illuminated suction
apparatus having a suction tube, an optical waveguide, a first
handle coupled to the suction tube and optical waveguide, and at
least one total internal reflection (TIR) preserving element
coupled to the optical waveguide, wherein the suction tube, optical
waveguide, first handle, and the at least one TIR preserving
element are coupled together to form a single handheld instrument;
promoting total internal reflection of light passing through the
optical waveguide with the at least one TIR preserving element;
advancing a distal region of the illuminated suction apparatus into
the surgical field; illuminating the surgical field with light from
the optical waveguide; and suctioning debris or fluid from the
surgical field with the suction tube while illuminating the
surgical field.
16. The method of claim 15, wherein the at least one TIR preserving
element comprises a first air gap between a proximal region of the
optical waveguide and the first handle, and wherein promoting total
internal reflection of the light passing through the optical
waveguide comprises maintaining the first air gap.
17. The method of claim 16, wherein the at least one TIR preserving
element comprises one or more standoffs disposed between a proximal
region of the optical waveguide and an interior wall of the first
handle, and wherein maintaining the first air gap comprises
providing the one or more standoffs.
18. The method of claim 16, wherein the at least one TIR preserving
element comprises a second air gap between the suction tube and the
optical waveguide, and wherein promoting total internal reflection
of the light passing through the optical waveguide comprises
maintaining the second air gap.
19. The method of claim 18, wherein the at least one TIR preserving
element comprises one or more standoffs disposed between the
suction tube and the optical waveguide, and wherein maintaining the
second air gap comprises providing the one or more standoffs.
20. The method of claim 15, wherein the at least one TIR preserving
element comprises an optical cladding disposed over the optical
waveguide, and wherein promoting total internal reflection of light
passing through the optical waveguide comprises providing the
cladding.
21. The method of claim 19, wherein providing the cladding further
comprises preventing the fluid and debris in the surgical field
from contacting the optical waveguide with the optical
cladding.
22. The method of claim 19, wherein the optical cladding comprises
a coating promoting the total internal reflection of the light
passing through the optical waveguide.
23. The method of claim 21, wherein at least one TIR preserving
element further comprises an air gap between the optical cladding
and the optical waveguide, and wherein the optical cladding is
configured to maintain the air gap.
24. The method of claim 23, wherein at least one TIR preserving
element further comprises one or more standoffs disposed between
the optical waveguide and the suction tube, and wherein the one or
more standoffs prevent engagement between a portion of the suction
tube with a portion of the optical waveguide thereby maintaining
the air gap therebetween.
25. The method of claim 15, wherein the first handle is
ergonomically configured to fit in an operator's hand.
26. The method of claim 15, wherein the illuminated suction
apparatus further comprises a pistol grip handle coupled to the
first handle.
Description
CROSS-REFERENCE
[0001] The present application is a continuation of U.S. patent
application Ser. No. 14/732,617 (Attorney Docket No. 40556-718.305,
filed Jun. 5, 2010, which is a continuation of U.S. patent
application Ser. No. 14/057,947 (Attorney Docket No. 40556-718.303,
now U.S. Pat. No. 9,072,452), filed Oct. 18, 2013, which is a
continuation of U.S. patent application Ser. No. 13/712,029
(Attorney Docket No. 40556-718.501, now U.S. Pat. No. 8,795,162),
filed Dec. 12, 2012, which is a continuation in part of U.S. patent
application Ser. No. 13/328,773 (Attorney Docket No. 40556-718.201,
now U.S. Pat. No. 8,568,304) filed Dec. 16, 2011, which is a
non-provisional of, and claims the benefit of U.S. Provisional
Patent Application No. 61/423,813 (Attorney Docket No.
40556-718.101, formerly 028638-001600US) filed Dec. 16, 2010; U.S.
patent application Ser. No. 13/712,029 (Attorney Docket No.
40556-718.501), filed Dec. 12, 2012, is also a continuation in part
of U.S. patent application Ser. No. 13/619,574 (Attorney Docket No.
40556-716.301, filed Sep. 14, 2012, which is a continuation of U.S.
patent application Ser. No. 12/616,095 (Attorney Docket No.
40556-716.201, now U.S. Pat. No. 8,292,805) filed Nov. 10, 2009;
the entire contents of which are incorporated herein by
reference.
BACKGROUND OF THE INVENTION
[0002] In various surgical procedures, illumination of the surgical
field is typically achieved through the use of headlamps and
surgical microscopes. There are scenarios in which these
illumination sources provide lighting that is either poor in
quality or poorly directed. As an example, during spinal surgery
from the lumbar approach, access to the desired anatomical target
area may be achieved through an angled incision on one side of the
patient's midline. Light emanating from an operating microscope is
static and may be poorly directed relative to the angle of surgical
access. Conversely, light from a headlamp may be adjusted as a
physician tilts or moves his head to redirect the output beam, but
still may be blocked by various anatomical structures such as the
spinous process or layers of tissue and muscle. Lighting from
either source may not be adequate as the physician progresses
through various phases of the procedure requiring visualization of
the anatomy at varied depths from the skin-level incision.
[0003] Hand-held instruments such as suction devices are routinely
used during surgical procedures such as spine surgery. These
devices are typically connected to a standard suction source in the
operating room, enabling the physician to dynamically and
efficiently remove blood, bone fragments, or fluid previously
irrigated into the surgical site. These suction devices are
sometimes also used to provide low force retraction of fat, muscle,
or other structures during the procedure. The surgeon holds the
suction device from its proximal end, manipulating the distal
portion of the suction device during the surgical procedure in
order to provide suction at the desired location. Hand-held suction
devices are widely available in a variety of distal tip
configurations suited to various surgical applications (Frazier,
Poole, Fukushima, etc).
[0004] Conventional suction devices have been constructed with
fiber optic cable encased in metallic tubing and connected to
metallic or non-metallic suction devices to provide some level of
illumination. These devices face multiple challenges.
Inefficiencies in the fiber-to-fiber coupling with high intensity
light leads to light losses at the interface which produces heat.
Losses are caused by non-transmissive zones between the optical
fibers and Fresnel reflections at the interface. The spatial zones
between the fibers are frequently the dominant cause of light loss
and heat. Excess heat at the interface can cause thermal damage to
the tissues and is also a fire hazard in the operating room. Some
manufacturers recommend limiting the amount of light that can be
transmitted to the operative device and interface, reducing the
inherent heat transmission.
[0005] Therefore improved illuminated suction apparatuses are still
needed. At least some of the challenges described above will be
overcome by the embodiments disclosed herein.
SUMMARY OF THE INVENTION
[0006] The present invention relates generally to the field of
surgical illumination and more specifically to illumination systems
with integrated surgical tools.
[0007] The devices described below provide improved illumination in
a surgical suction device. The illuminated suction device described
below includes a metal or non-metallic suction tube having a
proximal end and a distal end connected by a central portion. The
proximal end of the suction tube is provided with fittings for
connection to a vacuum source. The suction tube has an inner
surface and an outer surface, with a layer of optical cladding
having a refractive index that may be between 1.29 and 1.67 on the
outer surface of the central section of the suction tube, and an
illumination waveguide having a proximal end and a distal end. The
illumination waveguide is formed surrounding the optical cladding
on the central portion of the suction tube, and serves to conduct
light around the suction tube from the proximal end to the distal
end of the illumination waveguide. The illumination waveguide may
have a refractive index between 1.46 and 1.7 and may have a
numerical aperture between 0.33 and 0.70. An illumination input is
formed into the proximal end of the illumination waveguide for
conducting light from a source to the illumination waveguide.
[0008] The illuminated suction apparatus includes suction and
illumination functions integrated into a hand-held device suited to
meet the ergonomic needs of the physician. The hand-held,
repositionable suction function already prevalently used in
surgical procedures is surrounded by an illuminated waveguide which
enables the physician to apply lighting directly to the desired
region of the anatomy below the skin regardless of incision angle,
depth, and surrounding anatomical obstructions. The illumination
waveguide is a solid structure designed to specifically guide light
from a high-intensity light source and is fabricated using
injection molding of an optical-grade polymer with a specific index
of refraction such as cyclo-olefin polymer or copolymer or any
other suitable acrylic or plastic. Furthermore, the illumination
waveguide can be engineered to efficiently transmit light from its
distal output by sheathing or surrounding it with a second material
of lower index of refraction properly coordinated to the index of
refraction of the core material to preserve Total Internal
Reflection (TIR). This solid-state, structure guided illumination
waveguide is powered via a fiber optic cable connected to a high
intensity light source such as 300 W xenon sources supplied by
Luxtec, BFW, and others.
[0009] The illuminated suction apparatus may also include one or
more barbs, ridges or other protrusions on the proximal end of the
suction lumen enabling the connection of standard PVC surgical
tubing or other suitable vacuum conduit.
[0010] The use of a generally solid waveguide for suction
illumination, rather than optical fibers, eliminates losses due to
the non-transmissive spaces between the optical fibers and reduces
losses solely to those associated with Fresnel reflections. The
marked reduction in losses associated with a fiber/fiber junction
allows for high intensity light transmission to the waveguide
without significant heating of the interface or need for heat sink
devices or mechanisms at the interface. With a fiber to waveguide
connection, light from a standard 300 watt light source can be
transmitted with use of standard connectors such as ACMI, with a
steady state temperature below the temperatures harmful to body
tissue without design alteration. In some embodiments, a pigtail
connector may be used to introduce light into the waveguide. The
pigtail is a flexible optical input that is attached to a proximal
portion of the waveguide. It may be a bundle of optical fibers, or
a single flexible light pipe. The pigtail may be received in one or
more receptacles on the proximal portion of the waveguide and
bonded to the waveguide with an optical index matching adhesive. In
other embodiments, the pigtail may be may be formed by overmolding
the waveguide around the pigtail into a single integral part. The
pigtail may flare outward to match the width of the proximal
portion of the waveguide so that light is more evenly introduced
into the waveguide. In still other embodiments, the pigtail may be
used to provide other services to the device such as suction or
electrical current. For example, the pigtail may be a flexible
cable having multiple lumens. A lumen may be used to hold one or
more optical fibers for delivering light to the waveguide, while
another lumen may be used to provide suction to the suction tube
instead of having a separate suction tube. In some embodiments, a
lumen may be used to house one or more electrical conductors that
supply current to the suction tube or electrodes when the device is
used to deliver current to the tissue, or when the light source is
a part of the device. The pigtail may have any combination of these
features and is advantageous since it reduces the total number of
cables required and also helps keep device profile reduced.
[0011] Use of total internal reflection and light mixing in an
illumination waveguide (also referred to herein as an optical
waveguide) enables control of the output light profile and enables
custom illumination profiles. Microstructures such as facets,
lenses and or lens arrays can be applied to any suitable surfaces
of the illumination waveguide and light can be extracted
incrementally along the walls of the device with injection molded
structures and other suitable structures at minimal added cost. Use
of sequential extraction surfaces, changes in the numerical
aperture of the device as a function of position, use of extraction
structures--either micro or macro structural, with or without
changes in the numerical aperture, selective cladding, selective
reflective coatings, etc, all can be used to shape the output
profile of the waveguide to meet the design specifications or light
specifications requested by the user for specific surgical suction
illumination applications.
[0012] The device is meant to be disposable, fabricated out of low
cost materials to enable leverage of manufacturing efficiencies
through use of processes such as high-volume injection molding,
over-molding, and metal & polymer extrusion. Device assembly
would be engineered to minimize labor costs. A low cost,
high-performance combination device provides an attractive
alternative to existing discrete illumination and suction devices
while minimizing incremental cost to the user.
[0013] The illuminated suction apparatus comprises a hand-held
surgical device combining a high-performance illumination waveguide
with suction. This device would be useful in various surgical
procedures including open and minimally invasive orthopedics. The
illumination waveguide may also be combined with other surgical
devices such as surgical drills and probes, etc. The illumination
waveguide may be fabricated with fiber optic pigtails, index
matching liquid and or suction lumens.
[0014] The surgical suction field must be illuminated by the
illumination waveguide while the distal suction tip is in active
contact with the tissue and or fluid surface. To achieve this
effect, the output light from the illumination waveguide must
emanate from a point on the waveguide that is proximal to the
distal suction tip of the device. Where the design configuration
requires the light to exit from the waveguide proximal to the
distal tip of the surgical tool, the waveguide shape may be
configured to control the numerical aperture of the waveguide and
thus, the divergence angle of the exiting light. Similarly, one or
more refraction elements such as lenses of any suitable size may be
formed in or near the distal end of the waveguide to control the
light emitted from the waveguide. In surgery, when using a suction
illumination device in which the output light emanates from a point
proximal to the distal end of the device, a surgeon may experience
difficulty due to glare from the distal tip. Thus, a light source
such as an LED may be positioned adjacent the distal end of the
device, or the light source may be adjacent the proximal end of the
device such as in the handle, while in still other embodiments, an
external light source is utilized.
[0015] In an alternate configuration, the distal tip of the suction
tube may be configured to transmit light or reflect light such that
the surgeon sees the distal tip of the suction as illuminated such
that he/she can localize the distal tip of the suction device in
their peripheral vision without directly looking at or focusing on
the tip of the device. Extending a thin layer of the waveguide to
the tip can provide the effect. Strategies that implement this
effect include but are not limited to: (a) waveguide extended to
the tip with or without surface extraction features to cause light
to back reflect or scatter off the tip, (b) Use of a thin layer of
optically transmissive material with high scattering coefficient to
cause the suction device to glow (c) reflective surfaces applied to
the outside of the central suction device (d) reflective surfaces
applied with imperfections on the surface to reflect or scatter the
light off the outer surface (e) use of a cladding material applied
to the walls of the inner suction tube that transmits or scatters a
portion of the output light, the input to the cladding being either
an imperfection in the cladding or naturally occurring leakage, (f)
fluorescent coating on the tip, (g) phosphorescent coatings (h) use
of embedded or graded reflectors along or at the tip of the device.
Alternatively, the distal tip geometry could be formed to
intentionally scatter light (square edges, etc).
[0016] One or more surfaces in an optical waveguide sheath or
adapters or connectors may be polarized using any suitable
technique such as micro-optic structure, thin film coating or other
coatings. Use of polarized light in a surgical environment may
provide superior illumination and coupled with the use of
complementary polarized coatings on viewing devices such as cameras
or surgeon's glasses may reduce reflected glare providing less
visual distortion and more accurate color rendering of the surgical
site. One or more surfaces of an optical waveguide sheath may also
include light filtering elements to emit light of one or more
frequencies that may enhance visualization of specific tissues.
[0017] In a first aspect of the present invention, an illuminated
suction device comprises a suction tube having a proximal end, a
distal end, and a central portion therebetween. The proximal end is
fluidly connectable to a vacuum source, and the suction tube
further comprises an inner surface and an outer surface. An inner
layer of optical cladding is disposed circumferentially around the
outer surface of the central portion of the suction tube, and the
device also includes a non-fiber optic optical waveguide. The
optical waveguide has a proximal end, a distal end, and a central
portion therebetween. Light is transmitted through the waveguide by
total internal reflection and the light exits the distal end of the
optical waveguide to illuminate a surgical field. The optical
waveguide is disposed against the suction tube with the inner layer
of optical cladding disposed therebetween. The device also may have
an outer layer of optical cladding disposed circumferentially
around the suction tube and the optical waveguide.
[0018] The suction tube may comprise a tube having a cylindrically
shaped cross-section. Other cross-sections such as D-shaped, or
rectangular shaped may also be employed. The distal end of the
suction tube may be disposed further distally than the distal end
of the optical waveguide. The device may further comprise a suction
control mechanism disposed near the proximal end of the suction
tube. The suction control mechanism may be adapted to control
strength of suction provided by the suction tube. The suction tube
may also be electrically conductive and may act as an electrode for
conducting an electrical signal. A distal portion of the suction
tube main remain free of cladding. A portion of the suction tube
may remain unobstructed by the optical waveguide.
[0019] The inner layer of optical cladding may have an index of
refraction between 1 and 1.42. The inner layer of optical cladding
may form a tube having a substantially circular cross-section. The
inner layer of the optical cladding may be concentric with the
suction tube.
[0020] The optical waveguide may have a refractive index between
1.46 and 1.70. The optical waveguide may have a numerical aperture
between 0.33 and 0.7. The distal end of the optical waveguide may
comprise an array of lenses integrally formed in the distal end
thereof. The array of lenses may be arranged so that at least a
first lens overlaps with a second lens, and such that a spot of
light emitted from the first lens overlaps with a spot of light
emitted from the second lens. The distal end of the optical
waveguide may comprise a plurality of microstructures for
extracting light therefrom and the microstructures may be adapted
to direct the extracted light to form a pre-selected illumination
pattern. The optical waveguide may comprise one or more light
extracting structures near the distal end of the waveguide and the
light extracting structures may be disposed on an outer surface of
the optical waveguide. The light extracting structures may be
adapted to extract light from the optical waveguide and they may be
adapted to direct the extracted light laterally and distally away
from the optical waveguide to form a pre-selected illumination
pattern.
[0021] The optical waveguide may have an inner curved surface and
an outer curved surface, and the inner curved surface may have a
radius of curvature different than that of the outer curved
surface. An air gap may be maintained between the suction tube and
the optical waveguide. Standoffs may be disposed on the suction
tube or on the optical waveguide in order to prevent engagement of
the suction tube and the optical waveguide. This helps to maintain
the air gap between the suction tube and optical waveguide. The
optical waveguide may comprise a polarizing element for polarizing
light exiting the distal end of the optical waveguide. The distal
end of the optical waveguide may not be flat. Similarly, the
optical waveguide may also have a filter element for filtering
light so that one or more wavelengths of light are delivered to the
illumination area. In some embodiments, a barrier may be disposed
between the waveguide and the suction tube and the barrier prevents
fluids such as blood from wicking or otherwise traveling along the
space between the waveguide and suction tube.
[0022] The outer layer of optical cladding may have a refractive
index between 1.29 and 1.67. The outer layer of optical cladding
may form a tube that is non-concentric with the suction tube. A
portion of the outer layer of optical cladding may directly contact
a portion of the inner layer of optical cladding. In still other
embodiments, a layer of air may be disposed over a portion of the
outer surface of the optical waveguide to form an outer layer of
air cladding.
[0023] The device may further comprise a light conducting conduit
that is integrally formed as a single piece with the proximal end
of the optical waveguide, and the light conducting conduit may be
adapted to introduce light from a light source into the optical
waveguide. The light conducting conduit may comprise two light
conducting conduits each having substantially rectangular
cross-sections. The two light conducting conduits may be integrally
formed as a single piece with the proximal end of the optical
waveguide. The optical waveguide may be slidably coupled with the
suction tube. Therefore, proximal movement of the optical waveguide
relative to the suction tube increases spot size of the light
exiting the distal end of the optical waveguide. Also, distal
movement of the optical waveguide relative to the suction tube
decreases spot size of the light exiting the distal end of the
optical waveguide. The device may further comprise a handle coupled
to the proximal end of the optical waveguide and the proximal end
of the suction tube. An air gap may be disposed between the
waveguide and an inner surface of the handle. Standoffs may be
disposed on an inner surface of the handle or on an outer surface
of the optical waveguide in order to prevent engagement of the
handle and optical waveguide, thereby helping to maintain the air
gap therebetween.
[0024] In still other embodiments, the waveguide may be a molded
component having an elongate channel or lumen. The channel or lumen
may be used to apply the suction through the waveguide and thus a
separate suction tube is not required.
[0025] In another aspect of the present invention, a method of
illuminating tissue in a surgical field of a patient comprises
providing an illuminated suction apparatus having a suction tube
and a non-fiber optic optical waveguide that transmits light
therethrough by total internal reflection. The suction tube and
optical waveguide are coupled together to form a single handheld
instrument. The method also comprises positioning a distal end of
the illuminated suction apparatus in the surgical field, and
illuminating the surgical field by extracting light from the
optical waveguide. Light extraction features disposed on a distal
end or an outer surface of the optical waveguide are used to
extract the light, and also to direct the extracted light to form a
pre-selected illumination pattern in the surgical field. While
illuminating the surgical field, fluid or debris may be suctioned
from the surgical field with the suction tube.
[0026] The illuminated suction apparatus may comprise an inner
layer of optical cladding that is disposed around the suction tube.
The inner layer of optical cladding may be disposed between the
suction tube and the optical waveguide. An outer layer of optical
cladding may be disposed around both the suction tube and the
optical waveguide.
[0027] The distal end of the illuminated suction apparatus may be
positioned into engagement with the tissue while a distal end of
the optical waveguide does not engage the tissue. A distal end of
the optical waveguide may comprise an array of lenses integrally
formed therein. Illuminating the surgical field may comprise
projecting a spot of light from each lens in the array such that at
least a first spot of light overlaps with a second spot of light in
the surgical field. Illuminating the surgical field may also
comprise extracting light from the optical waveguide with one or
more light extracting structures. The extracted light may be
directed laterally and distally away from the optical waveguide.
Illuminating the surgical field may comprise illuminating the
surgical field with polarized light. Illuminating the surgical
field may comprise filtering light delivered by the waveguide so
that one or more wavelengths of light are delivered to the surgical
field.
[0028] The method may further comprise controlling suction strength
provided by the suction tube with a suction control mechanism. The
method may also comprise stimulating the tissue with electrical
current delivered by the suction tube. The optical waveguide may be
slidably positioned relative to the suction tube thereby allowing
an increase or decrease in spot size of the extracted light on the
tissue.
[0029] In still another aspect of the present invention, a method
of manufacturing an illuminated suction apparatus comprises
providing a suction tube having a proximal end, a distal end, a
central section disposed therebetween, an inner surface and an
outer surface, and providing a non-fiber optic optical waveguide
having a proximal end, a distal end, and an outer surface. The
optical waveguide transmits light therethrough by total internal
reflection. An inner layer of optical cladding is fit over the
outer surface of the central section of the suction tube, and the
optical waveguide is coupled with the suction tube with the inner
layer of optical cladding disposed therebetween. An outer layer of
optical cladding is fit over the outer surface of the suction tube
and over the outer surface of the optical waveguide.
[0030] The suction tube may comprise a tube having a circular
cross-section. The optical waveguide may have a first curved side
with a first radius of curvature and a second curved side with a
second radius of curvature. The first radius of curvature may be
different than the second radius of curvature. Fitting the inner
layer may comprise heat shrinking the inner layer onto the suction
tube. Coupling the optical waveguide with the suction tube may
comprise disposing the suction tube in an elongated open or closed
channel disposed along the optical waveguide. Fitting the outer
layer may comprise heat shrinking the outer layer onto the suction
tube and the optical waveguide.
[0031] In yet another aspect of the present invention, a hand held
illuminated suction device comprises a suction tube, a non-fiber
optic optical waveguide and optical cladding. The suction tube has
an inner surface, and outer surface, a proximal portion and a
distal portion. The proximal portion is configured to be fluidly
coupled to a vacuum source, and the distal portion is configured to
remove fluid or debris from a surgical field. The non-fiber optic
optical waveguide has an outer surface, a proximal region and a
distal region. The optical waveguide is disposed over the outer
surface of the suction tube, and light is transmitted from the
proximal region of the optical waveguide toward the distal region
thereof by total internal reflection. The light is emitted from the
distal region of the optical waveguide and directed distally to
illuminate the surgical field. The optical cladding is disposed
over the outer surface of the optical waveguide and prevents or
minimizes contact between the optical waveguide and the fluid, the
debris, or tissue in the surgical field. Thus, the optical cladding
promotes total internal reflection of the light transmitted through
the optical waveguide. The one or more standoffs are disposed
between the optical waveguide and the suction tube, and they
prevent engagement between a portion of the suction tube with a
portion of the optical waveguide thereby maintaining an air gap
therebetween. The air gap facilitates total internal reflection of
the light through the optical waveguide.
[0032] The device may also have a suction hole and a plurality of
fins that are both adjacent the distal portion of the suction tube.
The plurality of fins may be configured to prevent the tissue in
the surgical field from occluding the suction hole. The suction
tube may conduct electricity, and thus the suction tube may act as
an electrode for delivering current to the tissue in the surgical
field without requiring separate electrodes. Additionally, when the
suction tube serves as the electrode, because it is conductive,
conductor wires may not be required to run alongside the entire
suction tube since the conductor wire may be coupled to a proximal
portion of the suction tube. Any portion of the suction tube may be
insulated with a non-conductive layer such as heat shrink so that
the current exits the suction tube only at a desired point along
the suction tube. Furthermore, if the suction tube is malleable, it
may be bent or otherwise deformed into any desired shape to deliver
suction, illumination, and/or current to a desired position in the
surgical field. One or more electrodes may be coupled to the
suction tube. The electrodes may be configured to deliver current
to the tissue in the surgical field.
[0033] The optical waveguide may have a cross-section that changes
from the proximal region thereof toward the distal region thereof.
The optical waveguide may have a width and a thickness and the
width may increase or decrease from the proximal region thereof
toward the distal region thereof. The thickness may similarly
increase or decrease from the proximal region toward the distal
region. The illuminated suction apparatus may have an array of
lenses disposed on the distal region of the optical waveguide, and
the array of lenses may be configured to project the light into a
pattern in the surgical field. The light projected from each lens
in the array may form an illumination pattern, and the lenses may
be arranged to have a pitch so that the illumination patterns
overlaps with one another. The light may emanate from a region of
the optical waveguide that is proximal of the distal portion of the
suction tube.
[0034] The optical cladding may comprise an elongate molded polymer
element that may be rigid or flexible. The elongate molded polymer
element may have an elongate concave region that is configured to
receive the optical waveguide. The handle may be disposed over the
elongate molded polymer element.
[0035] The illuminated suction apparatus may further comprise a
first handle that is coupled to the proximal portion of the suction
tube and also coupled to the proximal region of the optical
waveguide. The first handle may be ergonomically configured to fit
in an operator's hand. The first handle may be disposed around the
outer surface of the optical waveguide with an air gap disposed
therebetween. The air gap promotes total internal reflection of the
light passing through the optical waveguide. The device may also
have a pistol grip handle that is fixedly or removably coupled to
the first handle. The device may also have a cradle that is
configured to receive the suction tube. The device may have a
suction control mechanism that is adjacent the proximal portion of
the suction tube. The suction control mechanism may be adapted to
control suction strength provided by the suction tube.
[0036] In still another aspect of the present invention, a method
for illuminating tissue in a surgical field of a patient comprises
providing an illuminated suction apparatus having a suction tube
and a non-fiber optic optical waveguide. The suction tube and the
optical waveguide are coupled together to form a single hand held
instrument. The method also includes maintaining an air gap between
the suction tube and the optical waveguide. The air gap promotes
total internal reflection of light passing through the optical
waveguide. Fluid and debris in the surgical field are prevented
from contacting the optical waveguide by providing an optical
cladding disposed over the optical waveguide. The optical cladding
also promotes total internal reflection of the light passing
through the optical waveguide. The distal region of the illuminated
suction apparatus is advanced into the surgical field, and the
surgical field is illuminated with light from the optical
waveguide. The light is directed to the surgical field by an array
of lenses disposed on a distal region of the optical waveguide. The
directed light forms a pre-selected illumination pattern in the
surgical field. While the surgical field is being illuminated,
debris or fluid such as blood may be removed from the surgical
field with the suction tube.
[0037] The optical cladding may comprise an elongate molded polymer
element that has an elongate concave region configured to receive
the optical waveguide. Illuminating the surgical field may comprise
positioning the distal region of the optical waveguide in the
surgical field without engaging the tissue. Illuminating the
surgical field may comprise projecting the light from each lens in
the array into an illumination pattern, and the lenses may be
arranged to have a pitch such that the illumination patterns
overlap with one another. Suction strength provided by the suction
tube may be controlled by providing a suction control mechanism.
Electric current may be delivered from the suction tube or from one
or more electrodes coupled to the suction tube to stimulate the
tissue.
[0038] These and other aspects and advantages of the invention are
evident in the description which follows and in the accompanying
drawings.
INCORPORATION BY REFERENCE
[0039] All publications, patents, and patent applications mentioned
in this specification are herein incorporated by reference to the
same extent as if each individual publication, patent, or patent
application was specifically and individually indicated to be
incorporated by reference.
BRIEF DESCRIPTION OF THE DRAWINGS
[0040] The novel features of the invention are set forth with
particularity in the appended claims. A better understanding of the
features and advantages of the present invention will be obtained
by reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention
are utilized, and the accompanying drawings of which:
[0041] FIG. 1 is a perspective view of an illuminated suction
apparatus.
[0042] FIG. 1A is a cross-section view of the illuminated suction
apparatus of FIG. 1 taken along A-A
[0043] FIG. 1B illustrates an exemplary embodiment of an
illuminated suction apparatus with electrodes.
[0044] FIG. 2 is a close up perspective view of the distal end of
the illuminated suction apparatus of FIG. 1.
[0045] FIG. 2A is a close up view of a single lens from the lens
array of FIG. 2.
[0046] FIG. 3 is a perspective view of an illuminated suction
apparatus with a handle.
[0047] FIG. 4 is a cross section view of the distal end of the
illuminated suction apparatus of FIG. 3 taken along B-B.
[0048] FIG. 4A illustrates an exemplary embodiment of light
extraction from a lateral surface of the illuminated suction
apparatus.
[0049] FIG. 5 is a cross section view of an illumination conduit
input according to the present disclosure.
[0050] FIG. 6 is a side view of an alternate illumination
conduit.
[0051] FIGS. 6A, 6B and 6C are various cross-section views of the
alternate illumination conduit of FIG. 6.
[0052] FIG. 6D is a perspective view of access port of the
alternate illumination conduit of FIG. 6.
[0053] FIG. 7 is perspective view of the illumination input of an
alternate illumination conduit.
[0054] FIG. 8 is perspective view of the illumination input of
another alternate illumination conduit.
[0055] FIG. 9 is a perspective view of an illuminated suction
apparatus with a handle.
[0056] FIG. 10 is a cross section view of the illuminated suction
apparatus of FIG. 8 taken along C-C.
[0057] FIG. 11 is a cross section view of the handle of the
illuminated suction apparatus of FIG. 10 taken along D-D.
[0058] FIG. 12 is a perspective view of an alternate illuminated
suction apparatus.
[0059] FIG. 13 is a perspective view of another alternate
illuminated suction apparatus.
[0060] FIG. 14 is another exemplary embodiment if an illuminated
suction apparatus.
[0061] FIGS. 14A-14B illustrate exemplary geometries of a
waveguide.
[0062] FIGS. 15A-15C illustrate an exemplary embodiment of an
illuminated suction apparatus with an adjustable illumination
waveguide.
[0063] FIG. 16 illustrates an exemplary cross-section of an
illuminated waveguide apparatus.
[0064] FIG. 17 illustrates another cross-section of an illuminated
waveguide apparatus.
[0065] FIGS. 18A-18B illustrate another embodiment of an
illuminated suction apparatus.
[0066] FIG. 19A illustrates a perspective view of the illuminated
suction apparatus in FIGS. 18A-18B.
[0067] FIG. 19B illustrates an alternative embodiment of the
illuminated suction apparatus in FIG. 19A.
[0068] FIG. 19C illustrates a cross-section taken along the line
C-C in FIG. 19B.
[0069] FIG. 19D illustrates a cross-section taken along the line
D-D in FIG. 19B.
[0070] FIGS. 20A-20C illustrate various partial cross-sections of
the embodiment in FIG. 19B.
[0071] FIG. 21 illustrates a perspective view of the embodiment in
FIG. 19B with the cladding and optical waveguide removed.
[0072] FIG. 22 illustrates the suction tube and cradle of the
embodiment in FIG. 19B.
[0073] FIG. 23 illustrates the suction tube of the embodiment in
FIG. 19B.
[0074] FIG. 24 illustrates the cladding of the embodiment in FIG.
19B.
[0075] FIG. 25 illustrates an exemplary optical coupling.
[0076] FIGS. 26A-26B illustrate an exemplary handle.
[0077] FIG. 27 illustrates an exemplary pistol grip handle.
[0078] FIGS. 28A-28D illustrate various light inputs to the
waveguide.
[0079] FIG. 29 illustrates an alternative embodiment of an
illuminated suction apparatus.
[0080] FIGS. 30A-30D illustrate exemplary embodiments of electrode
tips.
[0081] FIGS. 31A-31B illustrate an exemplary embodiment of an
illuminated and malleable suction device.
DETAILED DESCRIPTION OF THE INVENTION
[0082] Referring to FIGS. 1, 1A, 2 and 2A, illuminated suction
apparatus 10 includes suction tube 12 enclosing a suction lumen
12L. The suction tube in this embodiment or any of the embodiments
disclosed herein may be made of any suitable material such as a
metal like aluminum, stainless steel, or polymers such as acrylic,
ABS, PVC, and the like. The cross-section of this suction tube or
any suction tubes disclosed herein may be circular, non-circular,
D-shaped, rectangular, oval, or any other geometry may be used.
Illumination waveguide 14 is secured over cladding layer 15 on
central portion 12A of suction tube 12 leaving input or proximal
portion 12P and distal portion 12D exposed. Illumination waveguide
14 may have one or more sides, surfaces or other portions that are
configured such as flat side 14S or side 14T to optimize light
mixing as light 11L travels from illuminator input end 14P to exit
through light output face, or distal face 14F on output end
14D.
[0083] Illumination waveguide 14 is made of an optical grade
engineering thermoplastic such as cyclo olefin polymer which
efficiently transmits light. Any other suitable material such as
Cyclic Olefin Copolymer, Polycarbonate, Acrylic and or TPC may also
be used. Thus, the waveguide is preferably a single piece, formed
from a homogenous material. It may also be flexible or rigid and
self-supporting and thus is not a fiber optic which is unable to
support itself. The angles and bends of the waveguide structure are
engineered so light transmits through the waveguide via total
internal reflection (TIR). The side walls and other features have
angles and flat areas such that light is mixed and not allowed to
escape until it reaches the distal end 14D of the waveguide and
exits with a selected uniformity. Light that is reflected by TIR is
internally reflected with high efficiency (nearly 100% efficiency).
Suction tube 12 introduces a curved interface with illumination
waveguide 14 that changes the angle of reflection and creates
unwanted scatter of the light. Thus an uncoated or untreated
suction tube will cause a small portion of light to be lost to
absorption and or scattering at each reflection, ultimately
resulting in poor light transmission efficiency. In order to
preserve TIR through the waveguide, cladding material 15 with a
specific index of refraction is placed between the suction tube and
the waveguide. TIR can also be potentially disrupted by blood or
foreign matter from the surgical site coming into contact with
exterior exposed surface 14X of illumination waveguide 14. Exterior
cladding layer 15X having a specific refractive index can also be
attached to the outside of the waveguide. The waveguide material
may or may not completely surround suction tube 12 in order to
provide an illumination pattern from distal end 14D unobstructed by
a shadow from the metallic or malleable plastic suction tube. The
waveguide and TIR-preserving materials are chosen to provide an
optimized light exit angle, total light output, and illumination
suited to properly visualize the surgical site. Suction tube 12
could be treated (for example anodized in the case of aluminum) in
order to reduce glare or reflections resulting from interaction
with light output from the illuminator.
[0084] FIG. 1B illustrates an alternative embodiment of an
illuminated suction apparatus 10a having electrodes. One or more
electrodes 13e may be disposed on a distal portion of the suction
tube 12, and/or one or more electrodes 15e may be disposed on a
distal portion of the waveguide 14. The electrodes allow the
illuminated suction apparatus to be used as a probe for stimulating
various tissues such as nerves, or for cauterizing tissue. Wires or
other conductors may couple the electrodes to the proximal end of
the illuminated suction apparatus 10a which may then may be coupled
with an energy source that provides the current delivered by
electrodes 13e or 15e. The electrodes may be attached to the outer
surface of the suction tube, or a portion of the outer cladding 15
may be removed to allow the metal suction tube to be exposed and
used as an electrode. Thus, the suction tube itself may be used as
a conductor and electrode. Similarly, electrodes may be attached to
the outer surface of the waveguide, or a portion of the cladding
15X may be removed to allow portions of the waveguide to be exposed
and used as an electrode if conductive, or the electrodes may be
coupled to the waveguide. The illuminated suction apparatus may
then be operated in monopolar or bipolar mode.
[0085] FIGS. 30A-30D illustrate other exemplary embodiments of
electrode tips that may be formed into the suction tube. For
example, FIG. 30A illustrates suction tube 3002 having a
rectangular shaped electrode 3004a extending distally past the
distal edge of the suction tube. The width of the electrode 3004a
may be the same width as the suction tube, or it may be greater or
less. Additionally, the length of the electrode may be varied as
required. For example, FIG. 30B illustrates a similar rectangular
shaped electrode 3004b but that extends distally away from the
suction tube less than the previous embodiment. FIG. 30C
illustrates an electrode 3004c that is narrower than the suction
tube 3002 and it may be trapezoidally shaped, while in FIG. 30D,
the electrode 3004d is triangular shaped. The electrodes may be
formed by removing material from the suction tube so that a single
piece, integral device is formed, or the electrodes may be welded
or otherwise attached to the suction tube.
[0086] In an alternate configuration, distal face 14F of waveguide
14 may include any suitable surface treatment to control how light
11L forms illumination pattern 19. One or more lenses, or lens
arrays such as lens array 24 may be formed on distal face 14F.
Suitable optical features such as lens array 24 may include lenses
of identical, similar or different shapes and sizes to produce the
desired illumination pattern or patterns. Combinations of lens
shapes and radii may be used to optimize lens arrangement on the
distal or output face of the waveguide. The lens array may include
lenses on any portion of distal face 14F. Distal face 14F is
generally planar and may be described with respect to orthogonal
axes 26X and 26Y. Individual lenses of lens array 24 may also be
oriented differently, i.e. have a different pitch, relative to
planar axes 26X and 26Y. In one exemplary embodiment, a plurality
of lenses is disposed on the distal face 14F. Light is projected
from each lens distally toward the surgical field in an
illumination pattern. The pitch of the lenses may be adjusted such
that the illumination patterns are discrete and separate from one
another, or the pitch of the lenses may be adjusted such that the
illumination patterns overlap with one another. Overlapping
illumination patterns help eliminate non-uniform illumination that
results from optical defects in the lenses and/or waveguide.
Optical defects may be caused by parting lines, gates, scratches,
etc. in the optical waveguide and lenses. By overlapping
illumination patterns, the non-uniformities are "covered up" or
"washed out" by other illumination patterns provided by adjacent
lenses in the lens array. Additional details about this feature are
disclosed below.
[0087] Individual lenses such as lens 24A may adopt any suitable
geometry and may be curved or faceted with one or more facets such
as facets 25. Polygonal shapes such as lens 24A allow the lenses to
be located immediately adjacent to each other eliminating
undirected light leakage between the lenses.
[0088] In still other embodiments, the distal end of the waveguide
may be flat or it may be curved (convex or concave) in order to
help shape and direct light to the surgical field. Polarizing
elements or filters may also be coupled to the distal end so that
the waveguide delivers polarized light to the surgical field which
may be advantageous in preferentially visualizing certain tissues.
The polarizing elements may also be a wire grid polarizer.
[0089] FIG. 14 illustrates another exemplary embodiment of an
illuminated suction apparatus 1400. The illuminated suction
apparatus 1400 includes an illumination waveguide 1410 disposed
adjacent a suction tube 1402. The suction tube may be formed of
malleable metal or another malleable material such that it has a
straight relatively rigid distal section 1402r, and a pre-bent
flexible proximal section 1402f. The suction tube 1402 may be
joined to a flexible tubing 1406 that fluidly connects the suction
tube 1402 to a vacuum source (not illustrated) and thus the distal
tip 1404 of the suction tube 1402 may be used to remove fluid or
other material from the surgical field. Illumination waveguide 1410
is preferably a non-fiber optic waveguide (preferably as are any of
the waveguides described herein). The waveguide may be cylindrical
as illustrated in FIG. 14, or it may have other profiles such as a
square cross-section, rectangular, oval, elliptical, ovoid, etc.,
or any of the other geometries described herein. The pre-bent
malleable section 1402 allows a surgeon or other operator to bend
the suction device so that it can access various surgical sites and
accommodate differing anatomies. Another possible cross-section for
the illumination waveguide is illustrated in FIGS. 14A-14B where
the height h of the waveguide 1410a tapers down such that the
proximal end is higher than the distal end. Also, the width of the
waveguide 1410a may also increase from the proximal end to the
distal end as seen in FIG. 14B. This geometry results in a trumpet
shaped waveguide having a lower profile so that it may fit in a
smaller incision and take up less space in the surgical field.
[0090] In the embodiment illustrated in FIG. 14, the illumination
waveguide therefore has a flat upper surface and a flat lower
surface, as does the suction tube 1402. Therefore, the bottom
surface of the illumination waveguide lays flush against the upper
surface of the suction tube. An outer sheath 1414 such as heat
shrink may then be used to hold the illumination waveguide and
suction tube together. The outer sheath 1414 may be selected to
have desirable optical properties in order to minimize loss of
light. For example, FEP heat shrink has a desirable index of
refraction so that light is transmitted along the waveguide 1410
and then extracted from the distal portion 1412 using any of the
extraction features described herein. The outer sheath 1414 may
also be a tight fitting polymer sheath that is stretched over the
waveguide and suction tube, and may not be heat shrink tubing.
Additionally, a separate layer of cladding such as heat shrink
tubing or tightly fitting tubing (not illustrated) that can be
stretched may be disposed over the suction tube in order to
minimize light loss caused by contact between the suction tube and
the illumination waveguide. The separate layer of cladding may be
FEP tubing or any of the other materials described herein, and
preferably is disposed entirely around the circumference of the
suction tube. A fiber optic cable 1408 couples the illumination
waveguide with an external light source (not shown). The fiber
optics cable in this embodiment is preferably integral with the
waveguide (e.g. injection overmolded together) so as to be fixedly
connected to one another. In alternative embodiments, the fiber
optic cable is releasably connected to the waveguide. By joining
the fiber optic cable 1408 to the waveguide near the connection
point between the suction tube and flexible tubing 1406, allows the
surgeon or operator to easily flex or otherwise manipulate the
suction tube without interference from the fiber optic cable. The
fiber optic cable 1408 may be coupled with the waveguide 1402 such
that when the malleable bent portion 1402 is bent, the fiber optic
cable 1408 bends with the suction tube 1402f, or in other
embodiments, the fiber optic cable 1408 need not be coupled with
the bent malleable portion 1402f and may hang freely and
independently of the suction tube.
[0091] In any of the embodiments disclosed herein, the waveguide
position along the suction tube may be adjustable. For example, in
FIG. 15A illuminated suction apparatus 1500 includes an
illumination waveguide 1502 coupled to a fiber optic cable 1504.
The illumination waveguide 1502 is slidably disposed over suction
tube 1506 which is connected to flexible vacuum tubing 1508. The
waveguide may slide proximally or distally relative to the suction
tube 1506 and this permits regulation of light output spot size and
brightness in the surgical field. In FIG. 15B, the waveguide 1502
is advanced distally relative to the suction tube 1506 thereby
resulting in a smaller spot of light 1510 and a more brightly lit
distal tip of the suction tube and surgical field. In FIG. 15C, the
illumination waveguide is retracted proximally relative to the
suction tube and thus the light spot size 1510 is larger and more
diffuse than in FIG. 15B and therefore less brightly lighting up
the distal tip of the suction tube as well as less brightly
illuminating the surgical field. The waveguide 1502 in FIG. 15A may
have a circular cross-section or it may have other cross-sections
such as flat, curved, rectangular, or any of the cross-sections
disclosed herein. In some embodiments, the waveguide has a concave
inner surface that forms a saddle for receiving the suction tube,
and a convex outer surface. This allows the waveguide to be mated
with the suction tube with a low profile, as discussed herein with
respect to FIG. 16.
[0092] Referring now to FIG. 3, Light 11L from light source 11 is
conducted to the illumination waveguide using any suitable
apparatus such as fiber optic cable 11C and is then conducted
through waveguide 14 and exits from any appropriate structure or
structures on or near distal end 14D of the waveguide.
Alternatively, in this or any embodiment herein, the light source,
such as an LED could be integrated into the suction handle
eliminating the need for a fiber optic connection, or the LED may
be disposed distally, adjacent the distal tip of the device. Vacuum
from suction source 13 is conducted to illuminated suction
apparatus 20 using any suitable suction tube such as tube 13T which
is connected to vacuum input 22P. The vacuum available at the
distal end of suction tube 12 may be controlled by covering all or
a portion of suction hole H in handle 22.
[0093] Illuminated suction apparatus 10 may be integrated into a
handle such as handle 22 made of relatively low-cost engineering
plastic such as ABS or polycarbonate. Handle 22 may be formed from
two or more components that could be separate injection molded
components designed to be snap fit, glued, or ultrasonically welded
together. Alternatively, the handle could be formed over an
illuminated suction apparatus such as apparatus 10 through an
over-molding process. The proximal portion of the combined device
such as illuminated suction apparatus 20 would also contain a hole,
hole H, properly positioned to allow the surgeon to enable the
suction function by obstructing all or a portion of the hole with a
finger; the hole communicates with the suction pathway in the
device, disabling suction by creating a "suction leak" when it is
not blocked. Varying the hole geometry, as in the case of Fukijima
suction, affords finer modulation of the suction function. The
proximal end of handle 22 may also contain inputs for a traditional
fiber optic cable to be attached to illumination waveguide 14, such
as a male ACMI connection or other suitable connector, and a vacuum
port such as vacuum port 22P which may be a barbed fitting suitable
for standard flexible suction PVC suction tubing of various sizes
to be attached. The fiber optic cable is attached to a
high-intensity light source such as light 11. Suction tube 13T is
attached to any standard vacuum source in the OR such as a waste
collection container with integrated vacuum pump such as vacuum
source 13.
[0094] Referring now to FIG. 4, light beam 11B exits waveguide
distal face 14F at a specific angle based on the optical properties
such as the numerical aperture (NA) of the input source, index of
refraction of the material, and shape of the waveguide. Light
pattern 19 cast onto the target surgical field is optimized based
on the specific distance 16 the illuminator is set back from the
distal tip 12D of the suction tube. For a given light source
configuration, divergence angle 18 of light beam 11B results in a
specific illumination pattern 19 with a total light output and
illumination size 17 at any target plane normal to the illuminator
such as plane 21. The plane at the distal tip of the suction tube
is of particular interest, since the physician will place the
distal tip at the desired surgical target to enable suction or
retract tissue.
[0095] FIG. 4A illustrates an alternative embodiment of an
illuminated suction apparatus having light extraction features 23
on a lateral surface of the illumination waveguide that extract
light 25 and direct the light 25 laterally and distally toward the
surgical field. This may feature may be used alone or in
combination with the distal features previously described above.
The extraction features may include prisms, lenses, lenslets,
multiple facets, or other surface features known in the art that
extract light from the waveguide and direct the light to a desired
area in a desired pattern. The extraction features may be disposed
in a discrete area to extract light only from that area, or the
extraction features may be disposed circumferentially around the
waveguide so that a uniform ring of light emits from the waveguide.
Using both lateral extraction features and distal light features
allows diffuse light to emit from the lateral surfaces of the
waveguide while more focused light can be emitted from the distal
tip of the waveguide.
[0096] Referring now to FIG. 5, light source 11 is transmitting
light 11L into cyclo olefin polymer core 30 with refractive index
1.52, fluorinated ethylene propylene (FEP) cladding 32 with
refractive index 1.33, and an external environment 34 surrounding
cladding 32. Light source 11 is assumed to be in air with a
refractive index of 1 and a numerical aperture (NA) of 0.55 which
corresponds to a half-cone angle, angle 36, of 33.4 degrees. The NA
of source 11 is the angle of incidence on the core when light 11L
is coupled in which corresponds to angle 37. Internal light rays 31
initially enter core 30 at the half cone angle of 33.4 degrees and
are refracted at an angle of 21.2 degrees, internal refraction
angle 39 when they pass into core 30. Internal light 31 then
intersects core-cladding boundary 40 at an angle of 68.8 degrees
which is angle 41. As long as angle 40 is greater than the critical
angle determined by the core and cladding indexes, light 31 will
undergo TIR and none of light 31 will be transmitted into the
cladding. In this case (n-core=1.52 & n-cladding=1.33) the
critical angle is 61.0 degrees.
[0097] This ray trace can be worked backwards from the critical
angle to determine the maximum source NA that will still allow for
all light to undergo TIR at the core-cladding boundary. If
reflection angle 41 is 61.0 degrees which corresponds to the
critical angle for the selected core and cladding, then internal
refraction angle 39 is 29 degrees which means that angle 37 must be
47.4 degrees. From 47.4 degrees, the source NA is calculated to be
0.74. Therefore, when using the cyclo olefin polymer/FEP
combination, an input source with a much higher NA/Efficiency can
be used.
[0098] If the source NA is such that all the light coupled into the
waveguide undergoes TIR at the core-cladding boundary, then no
light is propagating in the cladding and the environment index does
not affect the waveguide transmission and no light is hitting the
cladding-environment boundary. The data in the following table
shows how the critical angle changes at the core-cladding boundary
as the cladding index changes from 1.0 to 1.46 for a cyclo olefin
polymer core (n=1.52). This is particularly relevant when designing
refractive structures. Knowing the critical angle ahead of time,
based on the environment or cladding, the structures can be
designed to preferentially leak light from the illumination
conduit.
TABLE-US-00001 Cladding Index Core-Cladding Critical Angle
(degrees) 1.00 41.1 1.10 46.4 1.20 52.1 1.30 58.8 1.40 67.1 1.417
68.8 1.42 69.1 1.44 71.3 1.46 73.8
[0099] When using FEP as a cladding with cyclo olefin polymer, the
critical angle is smaller than the angle from the 0.55NA (68.8
degrees). If no cladding is used, at the index of 1.417 and higher,
the critical angle equals to the input angle causing light leakage
because TIR is not maintained. Moreover, the combination of a cyclo
olefin polymer core with FEP cladding allows the use of an input
source with NA exceeding 0.55. The input source would enable
greater light capture from a source due to the larger acceptance
angle and provide more light through the illumination conduit
assuming constant transmission efficiency. Understanding the
critical angles of FEP and open environment, structures can be
designed more accurately to extract the light from the illumination
conduit.
[0100] Any suitable cladding materials such as FEP can be applied
to central portion 12A of suction tube 12 through methods such as
manual or semi-automated shrink-application of oversized FEP with a
heat gun or focused heat from a hot-box nozzle, leveraging FEP's
characteristic shrink ratio. Any other technique of a cladding such
as FEP may be used such as applying a liquid coating or vapor
deposition of FEP to central portion 12A or any other suitable
surface to be clad. Suction tube 12 with integrated cladding 15 can
then have illumination waveguide 14 insert-molded (via conventional
high-volume injection molding) and waveguide 14 will able to
maintain total internal reflection. Use of cladding 15 between
suction tube 12 and illumination waveguide 14 enables the suction
tube to be formed of any suitable material such as metal or
plastic. The choice of the plastic material for the suction tube
needs to be such that the index of that material is below 1.42 for
use with a waveguide having an index of 1.52 to maintain the
differential at the interface of the suction tube and the
waveguide. However, use of plastic may create challenges with
injection molding processes which require relatively high
temperatures and pressures inside of the molding cavity.
Alternatively the device can be manufactured such that illumination
waveguide 14 is formed with an internal lumen with no additional
suction conduit miming through it. The challenge posed by this
approach is the potential light transmission efficiency losses
stemming from evacuating biological material (blood, etc) through
the lumen and making contact with the internal surface of the
illumination waveguide lumen throughout the procedure.
[0101] Cladding with an index of 1.33 shows no light transmission
dependence on the refractive index of the surrounding environment
or the cladding thickness when used with an illumination waveguide
having a refractive index at or near 1.52. For a cladding with an
index of 1.33, the light coupled into the illumination waveguide is
constrained to the core due to total internal reflection at the
core-cladding interface. Thus, there is no light propagating
through the cladding, making the cladding-environment boundary
condition a negligible factor in transmission. Teflon FEP with an
index of 1.33 used as a cladding material with a cyclo olefin
polymer core with index 1.52, shows no dependence on cladding
thickness in three representative simulated surgical
environments.
[0102] While preferred embodiments use heat shrink as the cladding
over the suction tube and/or over the waveguide, in other
embodiments, a low index of refraction polymer may be injection
molded or otherwise formed over the waveguide. FIG. 17 illustrates
an illumination waveguide 1704 having such a polymer 1706 molded
thereover. This allows the polymer to minimize light loss from the
waveguide, and also allows the polymer 1706 casing to be used for
attaching to the suction tube or other surgical instruments. For
example, the two may be bonded together, solvent bonded, welded, or
otherwise joined together. In still other embodiments, snaps or
other coupling mechanisms may be joined to the polymer and suction
tube forming a snap fitting. Any number of coatings or claddings
may be used in the previous embodiment, or in any of the
embodiments described elsewhere in this specification. The coatings
or claddings may be used to enhance total internal reflection, or
the coatings or claddings may be used for to impart desired optical
properties to the light (e.g. polarize the light delivered to the
surgical field, etc.), or the coatings or claddings may be used to
provide a protective barrier against damage to the waveguide.
Multiple layers of coatings or claddings may be used. For example,
a low index of refraction coating or cladding may be applied to the
waveguide to help with total internal reflection, and then a
protective layer may be disposed thereover in order to help
minimize damage to the waveguide.
[0103] An illumination waveguide formed from material with a
refractive index of 1.46, showed light transmission dependence on
both cladding thickness as well as the external environment. This
is a result of introducing light into the illumination waveguide at
an NA of 0.55. Under this condition, light enters the core at an
angle that is less than the critical angle of the core-cladding
boundary, resulting in light propagating into the cladding. Since
light propagates through the cladding, the cladding-environment
boundary condition (critical angle) is a factor in the light
transmission. Due to light propagating through the cladding, the
cladding thickness also affects the transmission, because as the
thickness increases, the rays bounce at the boundaries fewer times
as they traverse the length of the waveguide.
[0104] Straight waveguide geometry in which the light traversing
the structure encounters no bends or radii results in the greatest
optical efficiency. However, due to ergonomic constraints or
compatibility & management of essential accessories related to
the device such as proximally attached fiber optic cables and
suction tubing, it may be advantageous to design the proximal light
input such that it creates an angle relative to the distal
transmission body of the waveguide structure.
[0105] Referring now to FIGS. 6 and 6A, to preserve TIR and
maximize transmission efficiency in illuminated waveguide 51 of
suction apparatus 50, central portion 52 between light input
section 54 and illuminated waveguide body 55 should be curved to
form angle 53 between the input and body as close to 180 degrees as
possible. Almost any bend or radius in the tube will cause some
light leakage. However, if angle 53 in central portion 52 is
limited to 150 degrees or greater, the light leakage is very low
and the light transmission efficiency is maximized. Where angle 53
is less than 150 degrees, light leakage may be reduced by reducing
or otherwise controlling the divergence of the light within the
waveguide or by using any other suitable technique.
[0106] The shape of illuminated waveguide 51 morphs or
cylindrically "sweeps" or "blends" from a solid cylindrical input,
input section 54 into a circular hollow tube of waveguide body 55.
Waveguide bore 56 may accommodate any suitable surgical tools such
as suction tube 58. Suitable surgical tools access waveguide bore
56 through access opening 59. As discussed above, light exits
waveguide body at or near distal end 60 with the majority of light
exiting through distal surface 61. Distal surface 61 may be flat or
it may any other suitable simple or complex shape. Distal surface
61 may have any of the surface features disclosed herein for
extracting and directing light to a field of illumination.
[0107] As the cross sectional area of illuminated waveguide 51
increases along the light transmission path from section 63 of
input section 54 to central section 65, to distal cross-section 67
near distal end 60, the NA of the illumination waveguide increases,
thus increasing the light divergence as light emerges from the
distal end of the illuminator. The NA can also be influenced by
bends. It may be possible to counter-bend to adjust the NA. Other
techniques for controlling the NA of the waveguide may also include
molding or machining features into the surfaces of the waveguide.
The concepts illustrated above can also be manufactured as two
halves that are over molded around any suitable surgical tool such
as suction tube 58. FIGS. 6A-6C illustrate various cross-sections
of the waveguide in FIG. 6, and FIG. 6D highlights the area
surrounding opening 59. Thus, in the embodiment of FIG. 6B, a
suction tube 1610 is disposed in the concave saddle portion 1604 of
the waveguide 1602 as seen in FIG. 16. Optical cladding 1606 such
as heat shrink tubing is disposed circumferentially entirely around
the suction tube 1610, and then another layer of optical cladding
1608 such as heat shrink is dispose entirely around the
circumference of both waveguide 1602 and suction tube 1610. A
portion of the cladding on the suction tube contacts a portion of
the outer cladding where no waveguide surrounds the suction tube.
Additionally, in this embodiment, the inner saddle has a first
radius of curvature and the outer surface has a different radius of
curvature (here larger than the inner radius of curvature).
Alternative embodiments may have other combinations of radii of
curvature.
[0108] Referring now to FIG. 7, disposable illuminated waveguide 70
can be supplied as a stand-alone device. Various suction devices or
other suitable tools such as suction tool 71 can be inserted though
central bore 72, the working channel of the illumination waveguide.
A connection could be constructed between waveguide 70 and a
surgical tool such as suction tool 71 that would allow the
waveguide to be secured to various suction devices, enabling both
waveguide 70 and suction tool 71 to be manipulated as a single
unit. This concept can be applied to other devices that would fit
through central bore 72 such as drills, etc. Additionally,
illuminated surgical apparatus 74 lends itself to dynamic
positioning of the waveguide 70 relative to any surgical tool
inserted in central bore 72, such as suction tool 71. For example,
the user could rotate the illuminator about the suction device as
in rotation 75, as well as telescope illuminator along the length
of the suction tube along path 76, repositioning or expanding or
contracting illumination field 77 as needed during the
procedure.
[0109] An alternative approach involves splitting the solid input
circle or ellipse such as input 78 of FIG. 7 and split input 80 is
formed as in FIG. 8 in which half of input light 11L is directed to
one half of the input, arm 82, and the other half of input light
11L is directed to the second half of the input, arm 83. Here, arms
82 and 83 come together in a generally rectangular cross-section as
input 80 to engage fiber optic cable 11C. However, input 80 can
have circular cross-section with semi-circular arm(s), elliptical
or multi faceted for better mixing of light. Inputs 78 and 80 may
be hollow or tubular and may also be shaped to operate as a lens or
may include a plurality of lenses. The configuration could also
have FEP cladding strategically applied to one or more areas of
each arm to preserve TIR. To enable proper function of the light
extraction features, holes, or other suitable shapes could be cut
into the FEP or other cladding, enabling a desired balance of TIR
preservation and suitable light leakage from specific zones of the
device. In the embodiments of FIGS. 6, 6A-6D, and FIG. 7, a fiber
optic cable may be coupled to the input portion of the waveguide
thereby allowing light from an external light source to be
delivered from the light source to the waveguide. The fiber optic
cable may be releasably coupled with the light input portion of the
waveguide, or the fiber optic cable may be a single piece fixedly
coupled with the light input portion of the waveguide and integral
therewith (e.g. by overmolding the fiber optic cable with the light
input portion of the waveguide). The integrated fiber optic cable,
or the releasably coupled fiber optic cable may be used with any of
the waveguide embodiments disclosed herein. The integrated fiber
optic cable or the releasable fiber optic cable may also be used in
any of the other embodiments disclosed herein.
[0110] During fabrication, particularly injection molding, various
artifacts may be formed in or on an optical part that may result in
unpredictable performance of the optical part. Features such a gate
scar, injector pin marks, parting lines, molded-in stress and any
bends or sharp edges may create irregular and unpredictable output
light patterns. To correct an irregular light output pattern the
output surface of the waveguide may simply be roughened which will
diffuse the light output. Roughened output surfaces cause
significant efficiency loss and raise the output angle of the
light. An alternative approach may be to create a pattern that
projects multiple overlapping images of the defect pattern which
will result in uniform illumination while minimizing efficiency
loss and output angle. This can be achieved with a lens array on
output surface such as lens array 24 of FIG. 2.
[0111] The design of a lens array for the input or output of an
illumination waveguide should consider the focal length of the
lenses, the quantity of lenses in the array, any suitable patterns
for the array, and the spacing between the lenses. The lens focal
length of the lenses needs to be selected to minimize diffusion,
and to maximize the radius of the lenses of the array. The lens
diameter should also consider the tooling to be used to create the
lenses. Tool marks left or created by the tooling should be a small
percentage of the diameter of the lenses. Similarly, making the
lenses too small makes them difficult to manufacture and diffuses
the light output. If the lenses are too large, there will be too
few overlapping images and the resulting light pattern will not be
uniform.
[0112] Incoherent and uncollimated light is going to diverge due to
the geometry and refractive index of the waveguide; any divergence
added by the lens array needs to be considered. Divergence of five
to 10 degrees due to the lenses would be selected to maintain
output light divergence close to the inherent divergence of the
waveguide.
[0113] Lens array pattern is also important. The lens array pattern
is a balance between manufacturing complexity and lens spacing.
Hexagonal lenses provide minimal inter-lens spacing and minimal
wasted space while maintaining light projection characteristics
similar to spherical lenses. A rectangular lens array pattern may
be selected of a square or rectangular spot pattern is desired.
Similarly, a rectangular illumination pattern may be produced by
varying the lens pitch between the X and Y dimensions in the plane
of the output face on which the lenses are formed. For example,
additional microstructure features can be added to the distal end
of an illumination waveguide to optimize control of the
illumination pattern as well as to homogenize the light output
field. Anti-reflection features, typically diffractive in nature
and sub-micron in size, can be added to the input and output faces
of the illuminator to reduce normal Fresnel reflection losses. The
features of the waveguide, such as curves, bends, and mounting
features, can cause undesired reflections, light leakage, glare,
and non-uniform output patterns resulting in poor performance.
Adding microstructure features which may be refractive or
diffractive on or near the distal portion of the illumination
waveguide can potentially provide better light uniformity and or to
bias the divergence or convergence of the illumination pattern as
well to homogenize the light output of the illumination field.
Features or tapering of the waveguide can also be added to the
outside of an illumination waveguide to control the illumination
output. Furthermore, micro lenses such as lens 78L or other
micropattern structures can be added to an illumination waveguide
input such as input 78 to better control the input beam shape or
other light input characteristics. The light input arm can be
round, square or multi faceted to provide a better mix of the
light.
[0114] The waveguide can be made in various shapes or cross
sections. Currently preferred cross-sectional shapes are round,
elliptical, or hexagonal. Other cross-sectional shapes such as
rectangles, triangles, or squares are possible. However, generally
regular surfaces of the waveguide, as well as odd number of
surfaces may cause a secondary pattern at the output. This pattern
would manifest as bright and dark spots. Cross sections resembling
even numbered higher order polygons such as the hexagon are
currently preferred. As the number of faces in the cross-section
increase, these cross sections would approach a circle, such a
device design would potentially complicate manufacturing processing
(such as injection molding), thereby increasing costs.
[0115] The illuminator can be tapered to increase or decrease its
cross section as light travels from the input to extraction zones.
Tapering biases the NA, causing either a tighter output spot (for
increased area at the exit) or a larger more diffuse spot
(decreased exit surface area, breaking TIR).
[0116] For an illuminated suction device, in many surgical
applications, there is a need for circumferential illumination
around the device. The illumination may need to be uniformly
circumferential or delivered in an off axis orientation for most of
the lighting to orient anterior to the retractor.
[0117] Referring now to FIGS. 9 and 10, handle 93 of illuminated
suction device 90 can be used to preserve TIR within illumination
waveguide 94 through creation of air gap 91 (n=1.0) around
waveguide 94. The design of the handle structure could include a
portion that partially or fully covers the length of waveguide 94
to create the desired air gap. Features such as standoffs 93X can
be molded into the surface of the handle in contact with the
illuminator and need to be located in optical dead zones (zones
where there is little or no TIR) to create a gap between components
and minimize light leakage through the contact points. A similar
configuration may be formed between suction tube 92 and illuminated
waveguide 94, air gap 95 can be formed without standoffs based on
the design tolerance between the ID of the illuminator and OD of
the suction tube or with one or more standoffs such as standoff 92X
or standoff 94X or any suitable combination. The air gaps between
the handle/waveguide and/or waveguide/suction tube may be used in
any of the illuminated suction apparatus embodiments disclosed
herein.
[0118] The divergence of light output from illuminated waveguide 94
can be controlled by permitting all or a portion of distal casing
96 to slide along axis 97 over the illuminator. The user can slide
the tube down over the illuminated waveguide 94 to reduce the
divergence angle and reduce the divergence of light 99L.
[0119] Referring now to FIG. 11, the design of handle 93 must
accommodate a suitable routing and termination of the suction
channel and solid-state illuminator such that a suction flow
control hole H is presented to the user in an ergonomically
favorable position. Based on the way a user is expected to hold and
manipulate an illuminated suction apparatus and the flow pattern of
evacuated material from the patient, hole H may be present at or
near the top surface 98 of the proximal handle. This can
accomplished by forming handle 93 with at least two parts such as
top section 93T and bottom section 93B. In addition to providing a
shield for and proximal terminus for the illuminated waveguide 94,
top handle portion 93T also contains suction flow control hole H.
Suction flow control may also be provided by a valve or other
similar apparatus that enables controlled adjustable suction. The
top and bottom handle portions are sealed, with the bottom portion
93B creating a chamber in communication with proximal termination
92P of suction tube 92. Evacuated debris can be kept from flowing
through to vacuum tube conduit 93P and out of hole H based on the
geometry of the chamber 100 and pathway to flow control hole H.
Alternatively a "strainer" or "filter" such as filter 102 may be
included in handle 93 to capture any solid or liquid debris and
prevent the debris from making their way out through hole H.
Features in handle 93 could also allow the user to disassemble the
top and bottom portions to clear any collected debris. The suction
control mechanism may be used in any of the embodiments disclosed
herein.
[0120] While the concepts presented thus far focus on a completely
disposable non-modular device, alternative architectures are
possible including the following:
[0121] a. Disposable suction tips (varying French sizes &
styles such as yankaeur, etc.) that integrate with a disposable
device through a "quick-connect" attach & detach scheme.
[0122] b. Disposable illumination sheaths such as waveguide sheath
may accommodate any suitable surgical instrument such as for
example, a drill, burr or endoscope which is encased, enclosed or
otherwise surrounded by optical waveguide sheath. Illumination
sheaths can be various materials such as flexible silicone.
[0123] c. Disposable distal suction tips or other implements (nerve
probes, etc) can also be integrated with a reusable proximal
illuminator containing a traditional fiber optic bundle. This would
enable rapid tip style exchange without the need to unplug cables.
This approach also provides a means of unclogging trapped evacuated
material.
[0124] d. Reusable proximal handles with removable single use
illuminators/suction tubes. Enables easy change-out of devices
without need to unplug cables.
[0125] Referring now to FIG. 12, suction lumen 108 may be formed in
suction element 109 that may be formed around an illuminator such
as waveguide 110, as shown in illuminated suction apparatus 111.
This configuration would allow for output light 112 to exit from a
cylindrical source such as waveguide 110 without the shadowing
caused by having a central illumination tube coaxial to the
illuminator.
[0126] The routing of the suction conduit through the illuminator
can be varied to optimize the illumination output and balance
ergonomic considerations.
[0127] Referring now to FIG. 13, illuminated suction apparatus 116
is configured to enable suction tube 118 to be strategically routed
through illumination waveguide 120 at angle 121 such that (1)
proximal exposed end 118P is at the top of the device where the
suction control function can be more readily accessed by the user;
and (2) distal end 118D of the suction tube emerges from the bottom
of the device below illumination output 122, providing optimized
lighting of the surgical site from above the suction tube. In this
configuration the suction tube changes light transmission paths
through the illumination waveguide by introducing reflective
surfaces which more thoroughly mix the light. It is possible to
maintain the efficiency by using high reflective coatings, air gaps
and cladding such as cladding 123. However, the added reflectance
surfaces of the suction tube may cause the NA to increase.
[0128] Rotationally symmetric illuminated suction devices such as
illuminated suction apparatus 116 may produce circumferential,
uniform light output with strategic positioning of the suction tube
that mitigates shadowing from the suction tube protruding from the
distal surface of the waveguide. Light traversing the illuminated
waveguide may have challenges with secondary reflectance surfaces,
thus widening the light output pattern. Illuminated suction
apparatus 116 is also expected to have a very large NA.
[0129] Illumination waveguides such as waveguides disclosed above
may also be made malleable out of material like silicone. This can
be useful to "pull over" an instrument like suction tube. The
illumination waveguide can be made of a malleable material such as
silicone allowing it to be pulled over a rigid suction tube,
potentially lowering cost. Alternatively the malleable illumination
waveguide material can be formed over a deformable suction tube
structure, or a deformable structure that contains selective
strength members (beams, etc). This would enable dynamic shaping of
the suction tube to various desired shapes suited to the clinical
application.
[0130] The illumination waveguide can be fabricated with materials
of varying indices in a "stacked" or "composite" structure to shape
and control the light output.
[0131] An alternative approach involves splitting an illumination
waveguide with a solid light input with a circular or elliptical
cross-section, routing and re-combining the waveguide into the
original starting geometry. An illumination waveguide can then be
molded over an internal suction tube. Alternatively, the suction
tube in this configuration could run alongside the spit illuminator
geometry.
[0132] If the cross section area is maintained (that is, distal and
proximal ends on either side of split have same cross section, the
intermediate shape of the waveguide can be manipulated. In the
configuration listed above, there should be no significant loss of
efficiency or change in NA. Thus, the input and output light
patterns should be very similar in shape and intensity.
[0133] FIG. 29 illustrates yet another embodiment of an illuminate
suction apparatus 2902. The suction apparatus 2902 is a single
molded piece 2904 that functions both as a suction tube and also as
a waveguide. The molded piece 2904 is an elongate tubular structure
having a lumen 2906 extending through the molded piece 2904. Thus,
the molded piece 2904 may be used as a waveguide to transmit light
distally by total internal reflection, and the lumen 2906 may be
used as a suction tube to remove fluid and other debris from a
surgical field. Light exiting the distal face 2910 illuminates the
surgical field, and the distal end 2912 of the lumen is used to
suction fluid and debris. The distal end 2912 of the lumen and the
distal face 2910 may also be offset from one another and in
preferred embodiments, the distal face 2910 is more proximal than
the distal end 2912 of the lumen. Vacuum may be applied to the
lumen 2906 using standard connectors and fittings, and light may be
input into the waveguide using techniques known in the art. This
embodiment has certain advantages such as allowing it to be molded
as a single piece, and does not require a separate suction
tube.
[0134] FIGS. 18A-18B illustrate another exemplary embodiment of an
illuminated suction apparatus 1802. The apparatus 1802 includes an
optional pistol grip handle 1804, a main handle 1806 formed from
right and left handle sections 1806a, 1806b, a suction tube 1816, a
non-fiber optic optical waveguide or illuminator 1820 (best seen in
FIG. 18B) for emitting light 1818, an optical cladding 1812,
optical connector 1810, and vacuum fitting 1808. FIG. 18B
illustrates an exploded view of the illuminated suction apparatus
1802.
[0135] All or a portion of the suction tube tip may be modular such
that a suction tip may be easily removed from the device and
substituted with another suction tip depending on the anatomy being
treated or the application (e.g. suction only, suction with
electrical stimulation, etc.). Thus, various low profile tips may
be provided with the illuminated suction device. The tips may be
releasably coupled to the rest of the device using any number of
quick release mechanisms such as bayonet fittings, threaded
fittings, snap fits, detent mechanisms, etc.
[0136] FIG. 19A illustrates a perspective view of the illuminated
suction apparatus 1802 in FIGS. 18A-18B. The distal portion of the
suction tube 1816 has an enlarged or bulbous head region 1824 to
help prevent causing trauma with tissue during use. Additionally,
suction holes 1826 may be disposed circumferentially around the
outer surface of the suction tube 1816. The distal end of the
suction tube may also have a suction hole 1828 for suctioning blood
or other fluid and debris from the surgical field. The distal tip
of the optical waveguide may include surface features 1822 for
extracting and directing light to the surgical field. In this
embodiment, the surface features form an array of lenses like those
previously described above. Any of the surface features described
herein may be used on the distal tip or on an outer surface of the
distal region of the optical waveguide to extract and direct light
to the surgical field. Some embodiments may have extraction
features such as prisms, facets, lenses or other extraction
features on an outer surface of the waveguide so that light is
extracted from the outer surface of the waveguide and directed
radially outward and circumferentially from the outer surface of
the waveguide. The waveguide may be coated or clad with a layer of
optical material to prevent light from leaking out. Exemplary
cladding includes low index of refraction heatshrink materials. Air
may also be used as is discussed below. FIG. 19A also illustrates
the vacuum fitting 1808 which may be a standard barbed fitting,
quick disconnect, or other fitting known in the art to allow the
suction tube 1816 to be fluidly coupled to a vacuum source. The
optical fitting 1810 may be any standard optical fitting such as an
ACMI coupler to allow the optical waveguide to be optically coupled
with an external light source. In other embodiments, the optical
fitting 1810 may not be used, and the light source may include an
LED or other source of light disposed in the handle 1806 or
otherwise coupled to the illuminated suction apparatus 1802. In
still other alternative embodiments, the source of light such as an
LED may be disposed adjacent the distal tip of the optical
waveguide.
[0137] FIG. 19B illustrates an alternative embodiment of an
illuminated suction apparatus 1802 that is similar to the previous
embodiment with the main difference being that the distal portion
of the suction tube 1816 includes radially extending fins 1830 that
form a whisk-like basket on the distal portion of the suction tube.
The fins in the basket prevent tissue from being drawn into the
suction holes 1826 causing blockage. The fins may be fixed to the
suction tube or they may be radially expandable with adjustable
size. In some embodiments, the fins may be conductive and some or
all of the fins may also act as electrodes to electrically
stimulate the tissue.
[0138] FIG. 19C illustrates a cross-section taken along the line
C-C in FIG. 19B. It illustrates a distal portion of the illuminated
suction apparatus proximal of the lenses and distal tip of the
optical waveguide. The optical waveguide 1820 forms a C-shaped
structure having a concave inner surface that is shaped to match
the outer surface of the suction tube 1816, thus the concave region
forms a saddle that receives the suction tube 1816 in order to
minimize profile of the assembly. Additionally, the optical
waveguide flares outward and is at least partially, or fully
wrapped around the outer circumference of the suction tube, and
thus light emitted from the optical waveguide will
circumferentially illuminate an area around the suction tube. Thus
the waveguide may have a cross-sectional area that changes, here
increasing, while in other embodiments the cross-section may
decrease, or it may remain constant. The cradle 1814 also has
ledges which engage the optical waveguide to prevent or minimize
direct contact between the optical waveguide and the suction tube.
Preferably, an air gap is disposed therebetween. The air gap helps
promote total internal reflection of the light passing through the
optical waveguide. Contact between the optical waveguide and
adjacent structures such as the suction tube result in light loss
which reduces transmission efficiency of the optical waveguide.
Additionally, the outer shield or cladding 1812 similarly engages
ledges on the cradle to minimize or prevent direct contact between
the outer cladding and the optical waveguide by forming an air gap
therebetween. In some embodiments, it may be desirable to provide a
barrier that prevents blood or other fluid from wicking up the
suction device along the air gap. The barrier may be an O-ring,
adhesive, or any other material disposed between the waveguide and
suction tube, or anywhere else where there is a gap for fluid to
flow through such as between the waveguide and the outer shield.
The barrier may be placed anywhere along the device such as at the
distal tip, or more proximally to prevent the fluid from wicking.
The outer cladding is preferably a molded elongate cap element that
is placed over the optical waveguide to prevent blood or other
fluid and debris from contacting the optical waveguide. It is
preferably formed from a polymer having a low index of refraction.
The closer to an index of 1 (the index of refraction for air), the
better. In some embodiments, the cap may directly contact the
optical waveguide and light loss is minimized due to the refractive
index of the cap. In still other embodiments, instead of the cap,
only a layer of air cladding is disposed over an outer surface of
the waveguide.
[0139] FIG. 19D illustrates a cross-section of the illuminated
suction apparatus 1802 taken along the line D-D in FIG. 19B. It
illustrates a portion of the illuminated suction apparatus that is
more proximal than in FIG. 19C, and closer to the handle 1806. It
shows that the optical waveguide 1820 is cylindrical. Thus, it is
clear that the optical waveguide has a cross-section which changes
from the proximal end toward the distal end. In this embodiment, it
changes from the round cylindrical region to wider the C-shaped
distal region. Also, it is clear that thickness decreases distally
along the optical waveguide. FIG. 19D also illustrates the cradle
1814 with a channel 1902 having corners that engage the optical
waveguide 1820 at point contacts 1904 or with minimum contact
area.
[0140] FIGS. 20A-20C illustrate various partial cross-sections of
the illuminated suction apparatus 1802 in FIG. 19B. In FIG. 20A, a
portion of the handle 1806 has been removed to illustrate the air
gap 2002 that surrounds the optical waveguide 1822 in the handle
region, as well as the air gap 2004 that is circumferentially
disposed around the optical waveguide as it enters the optical
fitting 1810, here an ACMI adapter. Standoffs 2006 formed from ribs
in the handle have minimum contact with the optical waveguide and
help provide support to the optical waveguide so that the air gap
may be maintained. FIG. 20B illustrates a partial cross-section
taken along the line B-B in FIG. 20A and more clearly illustrates
the air gaps 2002, 2004 surrounding the optical waveguide 1820.
Additionally, ribs 2008 in the cradle 1814 also form standoffs that
help maintain an air gap 2010 between the optical waveguide 1820
and the suction tube 1816. FIG. 20C illustrates a partial
cross-section of the illuminated suction apparatus 1802 with the
cladding layer 1812 removed.
[0141] FIG. 21 illustrates a perspective view of the embodiment in
FIG. 19B with the cladding and the optical waveguide removed. This
view highlights the cradle 1814 which completely surrounds a
proximal portion of the suction tube 1816 and only partially
surrounds the suction tube toward the distal end thereof.
Additionally, a ledge or shelf 2102 forms standoffs that support
the optical waveguide, thereby helping to provide an air gap that
surrounds the optical waveguide.
[0142] FIG. 22 illustrates the suction tube 1816 disposed in the
cradle 1814 of the embodiment in FIG. 19B. It more clearly
illustrates the ledge 2102 which supports the optical waveguide.
FIG. 23 illustrates the suction tube 1816. It has a bent distal
portion that is shaped so that the handle may fit comfortably in
the operator's hand while allowing the tip to be easily inserted
into the surgical field. Any shaped may be used on the suction tube
depending on the anatomy being treated. The present embodiment and
shape may be used in general surgery procedures, as well as other
procedures. In still other embodiments, the suction tube may be
formed from a malleable material so that the operator may bent the
suction tube to any desired shaped. In still other embodiments, the
suction tube may be conductive and act as an electrode to deliver
current to tissue in the surgical field. In still other
embodiments, electrodes may be coupled to the suction tube. Any of
the electrode configurations described below may be used in this
embodiment. Additionally, the suction tube may be coated or covered
with a layer of insulation to prevent current from flowing out of
unwanted areas of the suction tube. FIG. 24 illustrates the
cladding 1812. As previously described, it preferably is an
injection molded elongate polymer element having an outer surface
2402 that is formed into a C-shaped component so that edges 2406
may be placed into engagement with the standoffs on the cradle to
minimize contact therebetween. Additionally, the concave region
2404 may be sized and shaped to match and receive the optical
waveguide while maintaining an air gap therebetween if desired, or
the cladding may directly engage the optical waveguide. Preferred
embodiments are formed from a material having a low index of
refraction in order to prevent or minimize light loss between the
cladding and the optical waveguide where the two components contact
one another.
[0143] FIG. 25 illustrates an exemplary optical coupling 1810 that
may be used with any of the illuminated suction embodiment
described herein. It preferably is compliant with other ACMI
optical couplings. The outer surface 2502 may be optically coupled
with an external light source. The internal channel 2504 is sized
to receive the optical waveguide. Ribs 2506 may be disposed in the
internal channel to minimize contact between connector and the
waveguide thereby allowing an air gap to be formed around the
optical waveguide which helps to minimize light loss.
[0144] FIGS. 26A-26B illustrate the right 2602a and left 2602b
halves of the handle 1806. The outer surface may be textured so
that the operator can easily grasp the handle. Additionally, the
handle 1806 may have an engagement mechanism 2604 such as snap
fittings or other mechanism for releasably or fixedly coupling the
optional pistol grip handle with the main handle. FIG. 27
illustrates the optional pistol grip handle 1804 which has a
central channel 2704 for receiving the main handle 1806.
Cooperating snaps or other engagement mechanisms 2702 may be
disposed on the pistol grip for releasably or fixedly engaging the
main handle with the pistol grip handle. The pistol grip handle may
have texturing or other surface features 2706 to facilitate
grasping by the operator.
[0145] In any of the embodiments described herein, the light input
may be coupled to a proximal portion of the optical waveguide using
a number of techniques. For example, in FIG. 28A, the light input
may be a single light pipe 2802a which is received in a receptacle
2806a in the waveguide 2804a. The light pipe 2802a may then be
bonded in position using an index matching optical adhesive. In
other embodiments, the waveguide may be overmolded around the light
pipe, thereby forming a single integral piece. In FIG. 28B, the
light input 2802b may be a bundle of optical fibers 2808b which are
received in the receptacle 2806b of waveguide 2804b. The fibers may
be bonded as described previously, or the overmolding processing
may be used. This light input may be referred to as a pigtail.
[0146] FIG. 28C illustrates a single optical light pipe 2802c which
flares outward 2810c to match the width of the optical waveguide
2804c. This helps spread the light along the width of the
waveguide, thereby more evenly distributing the light. FIG. 28D
illustrates a similar embodiment that uses a bundle of fibers 2808d
in the input 2802d instead of a single light pipe. The fibers flare
out 2810d to match the width of the optical waveguide 2804d. In any
of these embodiments, bonding, overmolding, or other techniques
known in the art may be used to couple the light input to the
waveguide.
[0147] FIGS. 31A-31B illustrate still another exemplary embodiment
of a malleable and illuminated suction device. The suction device
may have a suction tube 3106 that generally takes the same form as
any of the previously described suction tubes. However, in this
embodiment, the suction tube 3106 is malleable and thus it may be
bent in any direction in order to direct the suction to a desired
position in the surgical field. Additionally, if the suction tube
acts as an electrode or has electrodes disposed on it, bending the
suction tube also helps to direct electrical current to a desired
position in the surgical field. A waveguide 3102 that may take the
form of any of the previously described waveguides may be coupled
with the suction tube. A flexible light input 3104 maybe coupled
with the waveguide. The flexible input 3104 may take the form of
any of the previously described light inputs, including the pigtail
described above. In FIG. 31A, the suction tube 3106 is in a
substantially linear configuration. In FIG. 31B, the distal portion
of the suction tube has been deflected downward to form a curved
tip. The waveguide bends with the suction tube, and similarly, the
light input also flexes with the suction tube. Thus, the suction
tube may be bent in any direction without requiring the
re-adjustment of the waveguide or light input cable. In some
embodiments, portions of the suction tube may be rigid to prevent
them from being bent, while other portions may be bendable. For
example, the distal portion may be bendable, while the proximal
portion may remain rigid. Preferably, the bendable portions
maintain their bent positions until manipulated into another
position.
[0148] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. For example, any of the features disclosed in one
embodiment of an illuminated suction apparatus may be used in any
of the other embodiments of illuminated suction apparatuses
disclosed herein. It should be understood that various alternatives
to the embodiments of the invention described herein may be
employed in practicing the invention. It is intended that the
following claims define the scope of the invention and that methods
and structures within the scope of these claims and their
equivalents be covered thereby.
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